Kornimate/medical-research-clean huggingface dataset:
acute effects of spices on pathways associated with glucose homeostasis and inflammation on pbmcs of healthy subjects

Conditions: Healthy

Summary: this study aims to investigate the effect of spices on gene expression of pathways associated with glucose homeostasis, oxidative stress and inflammation, in the postprandial phase in healthy human subjects.


Eligibility criteria:
inclusion criteria: * healthy males and females * bmi 20-28 kg/m2 * must be able to accept spices * agreed and signed informed consent exclusion criteria: * below 18 years old * uncomfortable speaking english and/or difficulties in understanding spoken english * smoking or using snuss * vegetarian or vegan * stressed by venous blood sampling or previous experience of being difficult to be cannulated * receiving any drug treatment that may influence the study outcomes * pregnancy or breastfeeding

Keywords: spices functional food cardiometabolic risk metabolic syndrome inflammation peripheral blood mononuclear cell acute
a study of tas3351 in nsclc patients with egfrmt

Conditions: Non-Small Cell Lung Cancer

Summary: this is a first-in-human, open label, phase 1/2 study to investigate the safety and efficacy of tas3351 in patients with advanced or metastatic non-small cell lung cancer (nsclc) harboring an acquired c797s epidermal growth factor receptor (egfr) mutation.

this study will be conducted in 3 parts (i.e. dose escalation, dose expansion, and a phase 2 portion). the dose escalation part will investigate the safety and determine the recommended phase 2 dose and the recommended dosing regimen of tas3351 administered orally. the dose expansion part will explore the efficacy of tas3351 in nsclc patients with c797s egfr mutations. the phase 2 part will assess the efficacy of tas3351 in nsclc patients with c797s egfr mutations.

Eligibility criteria:
inclusion criteria: * locally advanced, non-resectable or metastatic nsclc * have adequate organ function * have a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) scale * has tumor tissue available to allow for analysis of egfrmt status dose escalation: • has any egfrmt status dose escalation back-fill part, dose expansion and phase ii: * has any sensitizing egfrmt and a confirmed c797s egfrmt * has measurable disease per recist v1.1 exclusion criteria: * participating in medical research not compatible with this study * symptomatic and unstable cns metastases * have not recovered from prior cancer treatment * have a significant cardiac condition * are a pregnant or breastfeeding female * a serious illness or medical condition * unable to swallow or digest pills

Keywords: non-small cell lung cancer nsclc egfr mutation c797s mutation tas3351
study of erlotinib with or without investigational drug (cs-7017) in subjects with advanced non-small cell lung cancer

Conditions: Advanced Non-small Cell Lung Cancer (NSCLC)

Summary: this is a phase 2 and open-label (subject will know the treatment he or she is receiving) study. the subject will receive either erlotinib alone or erlotinib + cs-7017 in this study. the study will determine what effect adding cs-7017 to erlotinib has on safety and length of survival in subjects with advanced non-small cell lung cancer who failed the first treatment.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage iiib or iv nsclc. * recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first line therapy. * measurable disease according to response evaluation criteria in solid tumors (recist) version 1.1 criteria. * ≥ 18 years of age. * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2. * adequate organ and bone marrow function. * resolution of any toxic effects of prior therapy (except alopecia) to national cancer institute common terminology criteria for adverse events (nci ctcae), version 4.0 grade ≤ 1. * agreement to use effective contraception while on treatment and for at least 3 months after end of treatment. exclusion criteria: * treatment with anticancer therapy within 3 weeks before study treatment. * therapeutic or palliative radiation therapy within 2 weeks or major surgery within 4 weeks before study treatment (except for radiotherapy for brain metastases). * administration of other thiazolidinediones (tzds) within 4 weeks before study treatment. * current need for concomitant use of other tzds during the study. * uncontrolled infection requiring iv antibiotics, antivirals, or antifungals, known human immunodeficiency virus (hiv) infection, or active hepatitis b or c infection at time of screening. * history of any of the following conditions within 6 months before initiating study treatment: diabetes mellitus requiring treatment with insulin or tzd agents; myocardial infarction with significant impairment of cardiac function; severe/unstable angina pectoris; coronary/peripheral artery bypass graft; new york heart association (nyha) class iii or iv congestive heart failure; malabsorption syndrome, chronic diarrhea (lasting \> 4 weeks), inflammatory bowel disease, or partial bowel obstruction. * pericardial or pleural effusion (eg, requiring drainage) or pericardial involvement with the tumor. participants with minimal pleural effusion may be eligible upon request by investigator and approval by sponsor. * pregnant or breast feeding. * prior treatment with epidermal growth factor receptor (egfr) inhibitors.

Keywords: nsclc
plasma circulating tumor dna analyses in er+ metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the purpose of this study is to evaluate whether increased mutant esr1 allele fraction in plasma ctdna 3-6 weeks after initiating salvage endocrine therapy is predictive of progression free survival in patients with er+ metastatic breast cancer.

the primary objective of this 110 patient correlative biomarker study is to evaluate whether changes in mutant esr1 allele fraction in plasma circulating tumor dna (ctdna) are predictive of progression-free survival in metastatic er+ breast cancer patients who are receiving 2nd, 3rd, or 4th line systemic endocrine therapy. a secondary goal of this study is to explore the prevalence and kinetics of hotspot and non-hotspot ctdna esr1 mutations in this patient population, prior to initiating a new line of endocrine therapy as well as upon clinical progression, to identify potential mechanisms of resistance. although initially to be opened at unc chapel hill, our goal is to expand enrollment to include rex cancer center in raleigh, north carolina, and collaborating institutions through the translational breast cancer research consortium.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age * female gender * biopsy proven diagnosis of breast cancer * stage iv disease diagnosed either by radiographic studies or biopsy * er+ by immunohistochemistry on primary and/or metastatic tissue biopsy (\>10%) * her2 non-amplified (1+ or below by immunohistochemistry, and/or her2 fish \<2 her2-to-cep17 ratio) * progressed on at least one prior line of endocrine therapy for metastatic disease * three or fewer prior endocrine-containing therapies for recurrent/metastatic disease * two or fewer prior lines of cytotoxic chemotherapy for recurrent/metastatic disease * plans to initiate 2nd, 3rd, or 4th line endocrine therapy for metastatic disease * recent re-staging scans within 4 weeks of study enrollment, with radiographically identifiable disease * no concurrent or prior diagnosis of malignancy other than breast cancer for the past 5 years. patients with a history of in situ cancer or basal or localized squamous cell skin cancer remain eligible * intends to pursue treatment as well as clinical and radiographic follow-up at unc health care * signed an institutional review board (irb)-approved informed consent document for this protocol and hipaa consent form exclusion criteria: * \< 18 years of age * tissue biopsies that support the presence of both er+ and er- metastatic breast cancer in the same patient * dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent * pregnant or lactating women

Keywords: dna circulating tumor cells
imn diameter to femoral canal diameter and union

Conditions: Femoral Shaft Fracture

Summary: to detect the relation between the intramedullary nail diameter to canal ratio and the incidence of non-union

femoral intramedullary nail fixation is currently considered the ''gold standard'' for treatment of femoral shaft fractures in adult population. clinical outcomes after operative treatment of proximal femur fracture have been shown to be dependent on achieving optimal mechanical alignment and union. patient independent risk factors associated with nonunion after intramedullary fixation includes: open fracture, undreamed intramedullary nailing, fracture comminution, non-isthmal and particularly infra-isthma fracture location and infection. patient dependent risk factors include smoking, diabetes, nonsteroidal anti-inflammatory medications, closed head injury and delayed weight. unreamed nailing allows for better maintenance of the endosteal circulation at the expense of smaller diameter implants; in contrast, reamed applications permit a larger diameter nail, resulting in stronger fixation constructs and earlier fracture union. after reaming, a larger diameter intramedullary nail is placed. when initially reported, this treatment resulted in high success rates.

Eligibility criteria:
inclusion criteria: 1. age (20_60) years old 2. closed fracture and open grade one 3. midshaft fractures type3\\2 according to the oa classification 4. pattern of the fracture (simple transverse,oblique ,spiral) 5. retrograde and antigrade nail exclusion criteria: 1. open fractures grade two and three. 2. patient with comorbidities eg(dm.htn...) 3. severe osteoporosis with wide medulla . 4. patient on regular steroid therapy. 5. patient refused to be enrolled in the study

Keywords: intramedullary nail
a study of ro5024048 in combination with ritonavir-boosted danoprevir with or without copegus (ribavirin) in interferon-naïve patients with chronic hepatitis c genotype 1 (inform-svr)

Conditions: Hepatitis C, Chronic

Summary: this multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination ro5024048 and ritonavir-boosted danoprevir with and without copegus (ribavirin) in patients with chronic hepatitis c genotype 1. in arm a and b, interferon treatment-naïve patients will receive 1000 mg ro5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. depending on viral response and treatment arm patients will be re-randomized to continue assigned treatment for additional 12 weeks or stop all treatment. the anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up. as of 29. september 2011, arm b patients (placebo-containing arm) will be offered, in conjunction with the current treatment, pegasys (peginterferon alfa-2a) 180 mcg subcutaneously weekly plus copegus 1000mg or 1200 mg orally daily for 24 weeks, with a 24-week follow-up.


Eligibility criteria:
inclusion criteria: * adult patient, \>/= 18 years of age * chronic hepatitis c of \>/= 6 months duration at screening * hcv genotype 1 and quantifiable hcv rna at screening (roche cobas taqman hcv test) * naïve for treatment with interferon (pegylated or non-pegylated) * body mass index (bmi) 18-35 inclusive, minimum weight 45 kg * females of child-bearing potential and males with female partners of childbearing potential must use 2 forms of effective non-hormonal contraception exclusion criteria: * pregnant or lactating women and males with female partners who are pregnant or lactating * decompensated liver disease or impaired liver function * cirrhosis or incomplete/transition to cirrhosis * non-hepatitis c chronic liver disease * hepatitis b or hiv infection * history of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin * history of pre-existing renal disease (except for nephrolithiasis) or severe cardiac disease * history of drug or alcohol abuse within the last year or alcohol consumption of \> 2 units per day; cannabinoid use is excepted
f@ce 2.0 a mobile phone-supported and family-centred rehabilitation intervention after stroke in uganda

Conditions: Stroke

Summary: the purpose of the present proposal is to implement and evaluate a new model for mobile phone supported and family-centred rehabilitation intervention (f@ce 2.0) with regard to functioning in activities in daily living and participation in everyday life among persons with stroke and their families (in rural and urban areas) in uganda.

the investigators' previous feasibility study suggested beneficial effects on self-efficacy and occupational performance and satisfaction of a mobile phone supported and family-centred rehabilitation intervention (f@ce1.0) after stroke in uganda. the purpose of the present proposal is to implement and evaluate f@ce on functioning in activities in daily living (adl) and participation in everyday life among persons with stroke and their families. with recommendations on evaluation of complex interventions both outcomes and processes will be studied and hence both quantitative and qualitative methods will be applied. in a randomized controlled trial f@ce 2.0 will be evaluated compared to ordinary rehabilitation in urban/rural uganda regarding; self-efficacy, perceived performance and participation in everyday activities, independence in adl, health care utilization and the families´ perceived participation in everyday activities. qualitative data will explore experiences of people with stroke and family members of participating in f@ce 2.0. this research program has a multidisciplinary perspective for sustainable rehabilitation, a prerequisite for better living conditions for people with stroke in low/middle income countries.

Eligibility criteria:
inclusion criteria: * stroke diagnosis identified with ct scan or clinical symptoms * inhabitant in a rural part of kalungu district, near masaka uganda, or kampala with surroundings * access to and ability to use a mobile phone * ability to speak and express themselves in english and/or luganda * modified rankin scale level 2 to 4. exclusion criteria: * none
pk and pd study of npi-001 and cysteamine bitartrate

Conditions: Cystinosis

Summary: safety, pharmacokinetics, and pharmacodynamics of npi-001 oral solution in cystinosis patients compared with cysteamine.

this study will examine the safety, pharmacokinetics, and pharmacodynamics of npi-001 oral solution in cystinosis patients, aged ≥ 10 years. the ability of npi-001 to reduce cystine will be assessed and compared with cysteamine.

Eligibility criteria:
inclusion criteria: 1. males or females, any race, ≥ 10 years of age. 2. diagnosis of nephropathic cystinosis and able to cease cysteamine therapy for 2 days. 3. females will be nonpregnant and nonlactating, and females of childbearing potential and males will agree to use contraception as detailed in the protocol. 4. able to comprehend and willing to sign an informed consent /assent form and to abide by the study restrictions (travel as necessary, clinical phase 1 unit or similar for up to 3 days). exclusion criteria: 1. have undergone kidney transplantation. 2. are receiving dialysis treatment. 3. history of significant hypersensitivity to nac or any ingredient of npi-001 oral solution. 4. participation in a clinical study involving administration of an investigational drug (new chemical entity) in the 30 days prior to day 1. 5. inability to provide blood samples, including difficulty with venous access. 6. subjects who, in the opinion of the investigator and/or sponsor (or designee), should not participate in this study.
evaluation of blood platelet indices,platelet aggregation in the activity of ibd patients on biological treatment

Conditions: Bowel Disease; Inflammatory Bowel Diseases

Summary: ulcerative colitis and crohn's disease, the two major forms of inflammatory bowel disease, are chronic, idiopathic, relapsing inflammatory conditions of the gastrointestinal tract. the mechanism is multifactorial and may result from the combined interaction of environmental, genetic, epithelial barrier defects, dysregulated immune responses, and microbial factors

histopathological examinations play a role in the diagnosis and management of uc, but they are costly and invasive. so, non-invasive inflammatory biomarkers of ibd, such as the wbcs, esr and crp are used in clinical practice . platelets play a critical role in blood hemostasis so impaired platelet activation may cause persistent mucosal inflammation. many studies have demonstrated that patients with ibd may have increased risks of venous thrombosis. thrombosis is a major cause of morbidity and mortality in ibd. platelet to lymphocyte ratio can be easily calculated from cbc can serve as useful biomarkers for predicting mucosal inflammation in uc. current disease management guidelines were focused on the use of anti-inflammatory agents, aminosalicylates, and corticosteroids. however, some patients are still refractory to these therapies. biological therapy has revolutionized the management of inflammatory bowel disease in the last few years. there available biologic medicines are infliximab, adalimumab, golimumab, vedolizumab, and ustekinumab. biological therapy brought a better control of inflammatory bowel diseases. its use requires specific care before the beginning and during the treatment.

Eligibility criteria:
inclusion criteria: 1. all patients diagnosed with inflammatory bowel disease ulcerative colitis or crohn's disease 2. all ibd patients received biological treatment 3. all ibd patients controlled with conventional treatment exclusion criteria: 1. ibs patients 2. ibd patients with: a) another autoimmune disease like itp and sle b) bleeding tendency as hemophilia or thrombophilia c) previous thrombotic events or on anticoagulants or antiplatelet drugs d) with another comorbidity as liver cell failure, respiratory failure, renal failure and cardiac failure
home-based augmented reality storybook training modules for children with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: autism spectrum disorder (asd) is a lifelong neurodevelopmental disability with increasing prevalence worldwide. the main difficulties include poor social interaction and self-regulation skills. effective interventions are required to improve the social interaction skills and emotional regulation of children with asd. the present study involved developing and testing the feasibility and short-term efficacy of the home-based augmented reality (ar) training modules for preschool children with asd. we recruited 15 children with asd (3 to 5 years old). wilcoxon signed rank test analysis was used to compare the differences in emotional functioning and adaptive behavior. children received 8-week home-based ar training modules. sessions were 20 minutes 4 times a week.

autism spectrum disorder (asd) is a lifelong neurodevelopmental disability with increasing prevalence worldwide. its symptoms include limitations in social interaction and repetitive and restrictive behaviors. these symptoms may result in difficulties in participating in daily life and social activities across the lifespan. the main challenges include poor communication, social interaction, and emotional regulation skills that can limit and impair a person's everyday functioning. many parents of children with asd had an increased caregiver burden. in addition, the total lifetime cost of autism per individual is about 3.6 million us dollars. thus, there is an urgent need to develop appropriate and effective interventions for improving the communication and self-regulation skills of children with asd. research has increasingly focused on the effectiveness of interventions for children with asd. nonetheless, research has yet remained an underappreciated concept in different cultural contexts. to address these gaps, the present study involved developing and testing the feasibility and effectiveness of the home-based augmented reality (ar) social story training modules for preschool children with asd. the home-based ar social story training modules are designed. we recruited 15 children with asd (3 to 5 years old). wilcoxon signed rank test analysis was used to compare the differences in emotional functioning and adaptive behavior. children received 8-week home-based ar training modules. sessions were 20 minutes 4 times a week.

Eligibility criteria:
inclusion criteria: * the inclusion criteria were children who (1) had a disability identification for asd, (2) were aged 3 to 5 years and 11 months, and (3) scores at or above 30 according to the cars-2. exclusion criteria: * the exclusion criteria were children (1) whose nonverbal intelligence quotient was below 85 and (2) who had comorbid diagnoses with attention deficit hyperactivity disorder (adhd).
an open, randomised, single dose, 2-period, 2-sequence crossover adhesion study of two different transdermal patches containing rotigotine.

Conditions: Parkinson Disease

Summary: the objective of this study is to evaluate the adhesion of the test product when compared to the reference product following a single transdermal application.

the objective of this clinical trial is to evaluate the adhesion of the test product when compared to the reference product following a single transdermal application. the following evaluations will be assessed as "yes" or "no": * cold flow (dark ring formed around the patch) * patch movement/displacement * patch wrinkling * residue formation (at patch application on the release liner and at patch removal on the skin) safety and tolerability of a single dose application of a patch containing 18 mg rotigotine (test) against a patch containing 18 mg rotigotine (reference) will be evaluated in terms of vital signs and aes. aes and clinical tolerability will be monitored at all clinical trial visits. the safety evaluation will be based upon the review of the individual values (potentially clinically important abnormalities) and descriptive statistics (summary tables, graphics). as additional safety parameters for the clinical trial physical examination findings, clinical laboratory parameters, and 12-lead ecgs will be assessed at the screening and follow-up.

Eligibility criteria:
inclusion criteria: * patients diagnosed with idiopathic parkinson's disease assessed as eligible for receiving 18 mg/irr 8 mg/24 h rotigotine via the test and the reference product each on subsequent days in order to reach the dose of active substance at the individual routine medical care. patients should be on a stable rotigotine dose of at least 8 mg/24 h for at least 1 week before screening. exclusion criteria: * current participation in another clinical trial, participation in another clinical study (i.e. last protocol specified visit) involving another imp within at least 28 days prior to first application or previous participation in this clinical trial * history or presence of clinically significant dermatologic diseases or conditions, such as atopy, neurodermatitis, contact allergy, eczema, psoriasis, vitiligo, melanoma, squamous cell carcinoma. * history or presence of any dermatological condition or skin sensitivity that could affect imp absorption * history of clinically relevant (severe) hypersensitivity to the active pharmaceutical ingredient or substances of the same class or one of the excipients, clinically relevant allergy.

Keywords: adhesiveness